Cosmetics RP Services

Cosmetic UK Responsible Person Before your product can be placed on the UK market it must meet Regulation (EC) No

Medical Device Consultancy

Advena are the only consultancy team you need to bring your medical device through the ever changing regulatory hurdles to

UK Responsible Person

In order to place a medical device/IVD on the GB market, manufacturers based outside of the UK must appoint a

Advena ACTIV

Advena’s ACTIV system A full ISO 13485: 2016 system requires many different procedures and record types to be compliant, all

Auditing Services

Internal Audits To ensure impartiality and compliance, Advena are able to offer a tailored auditing service to the challenging requirements

Training Services

The world of Medical Device and In Vitro Diagnostic regulations is complex. Your team need to understand the entire process,

In-Vitro Diagnostic Consultancy

Advena are the only consultancy team you need to bring your IVD through the ever changing regulatory hurdles to approval.

Quality Management System (QMS)

A quality management system (QMS) is defined as a system of processes that ensures a high-quality approach and consistent results

Medical Device Single Audit Program

MDSAP is a single audit of your QMS by a recognised certification body, that aims to ensure the requirements of

PRRC Services

Person Responsible for Regulatory Compliance – PRRC Article 15 of both the Medical Device Regulation 2017/745 (MDR) and In-vitro Diagnostic

We continue to work with a number of trusted global partners, whom we have long standing relationships with. This enables us to ensure we can support clients who need regulatory and quality compliance outside of the UK and European Union, including our partner Advena Ltd (Malta).

Advena Ltd (Malta) offer EU Authorised Representative Services and both Medical Device Regulatory and Quality Management support to manufacturers based outside the UK and European Union.

Please visit for more details of their services.

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